OTC Medication Information: Abutol PARIS ANTISEPTIC HAND SANITIZER

ABUTOL PARIS ANTISEPTIC HAND SANITIZER- alcohol gel
ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Drug Facts

Active ingredient

Ethyl alcohol 70%

Purpose

Antiseptic

Uses

• hand sanitizer to decrease bacteria on the skin
• recommended for repeated use
• for use when soap and water are not available

Warnings

Flammable, keep away from fire / flame
For external use only

Do not use • in children less than 2 months of age
• on open skin wounds
When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water. • Do not inhale or ingest.

Stop and ask doctor if
• irritation and redness develop
• condition persists for more than 72 hours

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

Directions

• wet hands thoroughly with product and allow to dry without wiping
• supervise children under 6 years of age when using this product to avoid swallowing

Other information

• store between 15-30°C (59-86°F)
• avoid freezing and excessive heat above 40°C (104°F)
• may discolor certain fabrics or surfaces

carbomer, FD&C Red No.40, fragrance, glycerin, triethanolamine, water.

Distributed by: Daisy Distribution LLC, Wood Ridge, NJ 07075
Country Of Origin: Turkey

You may also report any serious side effects to
PO Box 328, Wood Ridge, NJ 07075-328

Lot No: 200620
Exp. Date: 06-2023
NDC: 77418-103-10

661799958837

•No Rinsing Required
•Does Not Dry The Skin

ALCOHOL CONTENT 70%

Packaging

IMAGE
(click image for full-size original)

ABUTOL PARIS ANTISEPTIC HAND SANITIZER
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:77418-103
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
FD&C Red No. 40
GLYCERIN
TROLAMINE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:77418-103-10 1 TUBE in 1 CARTON contains a TUBE
1 80 mL in 1 TUBE This package is contained within the CARTON (77418-103-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 06/08/2020
Labeler — ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI (566218248)
Establishment
Name Address ID/FEI Operations
ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI 566218248 manufacture (77418-103)

Revised: 06/2020 ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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